Table 3.
# | Scenario | Vaccine efficacy | DOP (months) | Disease burden | Source |
---|---|---|---|---|---|
1 | Baseline (VE 60%, DOP 5 m) | 60% (constant for all outcomes) | 5 | [7] | Assumptions |
2 | Baseline VE (60%) and minimum DOP (4 m) | 60% (constant for all outcomes) | 4 | [7] | Assumptions |
3 | Baseline VE (60%) and maximum DOP (6 m) | 60% (constant for all outcomes) | 6 | [7] | Assumptions |
4 | Minimum (VE 30%, DOP 4 m) | 30% (constant for all outcomes) | 4 | [7] | Assumptions |
5 | Minimum VE (30%) and baseline DOP (5 m) | 30% (constant for all outcomes) | 5 | [7] | Assumptions |
6 | Minimum VE (30%) and maximum DOP (6 m) | 30% (constant for all outcomes) | 6 | [7] | Assumptions |
7 | Maximum (VE 90%, DOP 6 m) | 90% (constant for all outcomes) | 6 | [7] | Assumptions |
8 | Maximum VE (90%) and minimum DOP (4 m) | 90% (constant for all outcomes) | 4 | [7] | Assumptions |
9 | Maximum VE (90%) and baseline DOP (5 m) | 90% (constant for all outcomes) | 5 | [7] | Assumptions |
10 | Prepare trial primary results VE and DOP | Cases = 39.4%; Hospitalization = 44.4%; Death = 48.3% | 3 | [7] | Prepare trial results (Phase 3), based on primary analysis that uses per protocol population [9] |
11 | Prepare trial expanded results VE and DOP | Cases = 40.9%; Hospitalization = 41.7%; Death = 59.6% | 3 | [7] | Prepare trial results (Phase 3), based on expanded analysis that includes additional population excluded per protocol [9] |
12 | Prepare trial primary results VE and DOP, under high burden | Cases = 39.4%; Hospitalization = 44.4%; Death = 48.3% | 3 | 8.7% of all LRTI deaths attributed to RSV, as suggested by new evidence [21], [22] | Prepare trial results (Phase 3), based on primary analysis that uses per protocol population [9] |
13 | Prepare trial expanded results VE and DOP, under high burden | Cases = 40.9%; Hospitalization = 41.7%; Death = 59.6% | 3 | 8.7% of all LRTI deaths attributed to RSV, as suggested by new evidence [21], [22] | Prepare trial results (Phase 3), based on expanded analysis that includes additional population excluded per protocol [9] |
14 | Baseline VE and DOP, under high burden | 60% (constant for all outcomes) | 5 | 8.7% of all LRTI deaths attributed to RSV, as suggested by new evidence [21], [22] | Base case vaccine efficacy and duration of protection under a high burden scenario |
Abbreviations: DOP, duration of protection; VE, vaccine efficacy; LRTI, lower respiratory tract infection; m, month.